DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/10/2026 has been entered.
Withdrawn Objection
The objection to claim 27 is withdrawn in response to the amendments.
The rejection of the claims under 112(a) written description is withdrawn in response to the amendments.
Priority
The present application was filed on 2/9/2022 and is a CON of PCT/JP2020/032656, filed 8/28/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. JP2019-158952, filed on 8/20/2019 in Japan, to Application No. JP2019-158962, filed on 8/20/2019 in Japan and to Application No. JP2019-158138, filed on 8/20/2019 in Japan .
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Status of the Claims
Claims 1-32 are pending; claims 1 and 27 are amended; claims 12-26 and 32 are withdrawn. Claims 1-11 and 27-31 are examined below.
New Claim Objection
Claim Objections
Claims 1are objected to because of the following informalities:
In claim 1 line 17, "Dw is 144-289.1 nm" appears to be a typographical error, namely it is suggested that "Dw is 144-289.1 nm" read as "Dw is from 144 to 289.1 nm" to clearly recite a range of values and improve clarity.
In claim 2 line 1, “which has” appears to be a typographical error, namely it is suggested that “which has” read as “wherein the particle has” to conform with conventional claim language.
Appropriate correction is required.
New Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 27-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 and its dependent claims require “[a] particle formed from a copolymer derived from at least one (meth)acrylate monomer, the particle comprising: a particulate copolymer containing glycidyl (meth)acrylate and styrene; an epoxy group derived from glycidyl methacrylate on the surface of the particulate copolymer; and a repeating unit A and a repeating unit B derived from the epoxy group; repeating unit A having a side chain A, the side chain A having at a terminal thereof a carboxy group configured to be bonded to a ligand; repeating unit B having a side chain B, the side chain B having a hydroxy group at a terminal thereof; and the particle being configured such that when the particle is dispersed in ion-exchanged water, the surface of the particle hydrates and forms a swollen layer, wherein a density of the carboxy groups incorporated into the swollen layer satisfies 0.04≤[Carboxy group density (group/nm3)]≤0.15, Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4 where a dry particle diameter (Dd) is measured by dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours, and a particle diameter in water (Dw) is measured at 25°C by a dynamic light scattering method in a state of dispersion obtained by dispersing the particle in ion-exchanged water having an electrical conductivity of 10 μS/cm or less such that the concentration of the particle is 0.001 mass%.”
However, the specification fails to provide support for “the particle comprising: a particulate copolymer containing glycidyl (meth)acrylate and styrene; an epoxy group derived from glycidyl methacrylate on the surface of the particulate copolymer; and a repeating unit A and a repeating unit B derived from the epoxy group;…”.
The specification discloses that “[t]he method includes a step 1 of mixing glycidyl (meth)acrylate, styrene, divinylbenzene, water, and a radical polymerization initiator to form a particulate copolymer, thereby providing an aqueous dispersion of the particulate copolymer. The method includes a step 2 of mixing the aqueous dispersion, 3-mercapto-1,2-propanediol, and mercaptosuccinic acid to prepare a mixed liquid, followed by causing of an epoxy group derived from glycidyl (meth)acrylate of the particulate copolymer, and a thiol group derived from each of 3-mercapto-1,2-propanediol and mercaptosuccinic acid to react with each other to form the particle of the first embodiment” (para. 46). Therefore, the specification discloses that the particle is formed via a polymerization reaction with a particulate copolymer, i.e. that a particulate copolymer is used to synthesize the claimed particle (see also “(Synthesis of Particles 1-1)” paras. 206-207). The specification fails to disclose that the particle comprises the particulate copolymer, an epoxy group derived from the particulate copolymer and a repeating unit A and repeating unit B derived from the epoxy group as claimed.
Claims 1-11 and 27-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not reasonably provide enablement for “a density of the carboxy groups incorporated into the swollen layer satisfies 0.04≤[Carboxy group density (group/nm3)]≤0.15”.
The specification does not provide sufficient evidence that the claimed particle can effectively incorporate a carboxy group density (group/nm3) into the swollen greater than or equal to 0.04 and less than or equal to 0.15. The evidence provided merely states a disclosure of the calculated carboxy group density (Table 1-1 para. 292). The specification discloses a method to measure the carboxy group density based on a series of reactions (paras. 58-66). “The carboxy group of the particle is turned into an active ester…After that, the active ester is caused to react with aminoethanol to liberate NHS, and a carboxy group amount per unit particle mass is calculated by determining the amount of the liberated NHS with a high-performance liquid chromatograph apparatus” (para. 59). Next, the carboxy group density is calculated using the “Formula (1-8)” (para. 70), i.e. “[Carboxy group density (group/nm3)]=Dd3/(Dw3-Dd3)xAxNAx 10-27” (para. 70). The method to calculate the carboxy group density assumes that the total content of carboxyl groups in the particle is incorporated into the swollen layer, without any evidence to support this assumption. Therefore, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied.
In re Wands, 858F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The nature of the invention is a biological/chemical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the claimed method(s), with a reasonable expectation of success, because it would not have been predictable from the disclosure that the claimed particle would function as claimed with respect to the particle incorporating specific carboxy groups into the swollen layer (see MPEP § 2164.03).
In regard to Wands factors (C), (D) and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a).
Accordingly, Santos et al. European Polymer Journal 43 (2007) 3314–3324 doi:10.1016/j.eurpolymj.2007.05.006 (“Santos”) teaches that “Alkali-thickening is a function of resin carboxyl content [11] and it has been reported that, for a fixed carboxyl content, carboxyl availability may change within the particle due to a core–shell morphology, which may be obtained from two stage and/or semi-batch polymerization processes [12]” (page 3315 col. 1 para. 2).
See also, Kawaguchi et al. Journal of Colloid and Interface Science Volume 176, Issue 2, 15 December 1995, Pages 362-369 https://doi.org/10.1006/jcis.1995.9956 (“Kawaguchi”). Kawaguchi teaches that “[t]he number of [carboxylic] acid groups is commonly determined by titration, either electrical conductometric or potentiometric. One commonly finds that there are fewer titratable acid groups than the acid comonomer used in latex synthesis, suggesting that some fraction of these groups are buried in the particle interior (5)” (page 362 col. 2 para. 3 and page 363 col. 1 para. 1). “We conclude that about 27% of total ionizable groups is buried in the particle interior” (Abstract).
Given the cited teachings of the prior art that the total carboxyl group content of the particle does not incorporate into the swollen layer, the cited references demonstrate that the use of a particle wherein a density of the carboxy groups incorporated into the swollen later satisfies 0.04≤[Carboxy group density (group/nm3)]≤0.15 is unpredictable.
While the level of skill in the art is high, the amount of guidance provided regarding how the particle incorporates the specific carboxy groups into the swollen layer is scant. Accordingly, the amount of experimentation required to determine how to use the recited particle is quite extensive.
Due to the large quantity of experimentation necessary to determine how the particle incorporates carboxy groups into the swollen layer, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the limited state of the prior art, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. §112 first paragraph.
Maintained Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 27-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and its dependent claims recite “[a] particle formed from a copolymer derived from at least one (meth)acrylate monomer, the particle comprising: a particulate copolymer containing glycidyl (meth)acrylate and styrene; an epoxy group derived from glycidyl methacrylate on the surface of the particulate copolymer; and a repeating unit A and a repeating unit B derived from the epoxy group; repeating unit A having a side chain A, the side chain A having at a terminal thereof a carboxy group configured to be bonded to a ligand; repeating unit B having a side chain B, the side chain B having a hydroxy group at a terminal thereof; and the particle being configured such that when the particle is dispersed in ion-exchanged water, the surface of the particle hydrates and forms a swollen layer, wherein a density of the carboxy groups incorporated into the swollen layer satisfies 0.04≤[Carboxy group density (group/nm3)]≤0.15, Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4 where a dry particle diameter (Dd) is measured by dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours, and a particle diameter in water (Dw) is measured at 25°C by a dynamic light scattering method in a state of dispersion obtained by dispersing the particle in ion-exchanged water having an electrical conductivity of 10 μS/cm or less such that the concentration of the particle is 0.001 mass%”.
However, it is not clear what is meant by “the particle being configured such that when the particle is dispersed in ion-exchanged water, the surface of the particle hydrates and forms a swollen layer, wherein a density of the carboxy groups incorporated into the swollen layer satisfies…Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4 where a dry particle diameter (Dd) is measured by dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours, and a particle diameter in water (Dw) is measured at 25°C by a dynamic light scattering method in a state of dispersion obtained by dispersing the particle in ion-exchanged water having an electrical conductivity of 10 μS/cm or less such that the concentration of the particle is 0.001 mass% ”. It appears that “Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4 …” does not limit the particle. The recitation “Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4 where a dry particle diameter (Dd) is measured by dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours, and a particle diameter in water (Dw) is measured at 25°C by a dynamic light scattering method in a state of dispersion obtained by dispersing the particle in ion-exchanged water having an electrical conductivity of 10 μS/cm or less such that the concentration of the particle is 0.001 mass%” is unclear because this does not satisfy any condition or limitation regarding the particle. The claim as currently recited suggests that “Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4” will satisfy a condition related to the density of the carboxy groups incorporated into the swollen layer, however, “Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1.4” merely recites that the particle has a particular diameter in water, a dry particle diameter and a ratio of between 1.10 and 1.4 between the two. The specification fails to clearly disclose how the carboxyl group density incorporated into the swollen layer satisfies Dw is 144-289.1 nm, and 1.10≤(Dw/Dd)≤1. A person having ordinary skill in the art would not be able to recognize the scope of the claimed invention based on the lack of clarity outlined above.
Furthermore, it is not clear what is meant by “where a dry particle diameter (Dd) is measured by dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours”. How can dropping a dispersion obtained by dispersing the particle at a concentration of 5 mass% in ion-exchanged water onto aluminum foil, drying at 25°C for 48 hours to obtain a dried product, and further drying the dried product with a vacuum dryer for 24 hours, enable measuring the dry particle diameter? This limitation does not appear to limit the measuring of the dry particle diameter and instead recites the drying of the particle. Therefore, person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim.
Claims 2-11 and 27-31 are included in this rejection because they depend from rejected claim 1 but fail to clarify the scope of patent protection sought.
Furthermore, claim 4 recites “…L1 represents an alkylene group or oxyalkylene group having 1 to 15 carbon atoms that may be substituted”. However, it is not clear what is encompassed by “having 1 to 15 carbon atoms that may be substituted” because the claim fails to recite the type of substitution or with what the carbon atoms get substituted. A person having ordinary skill in the art cannot recognize the metes and bounds of the claim.
Claim 5 recites “…L2 represents an alkylene group or oxyalkylene group having 2 to 15 carbon atoms that may be substituted…and X represents a sulfur atom or a nitrogen atom that may be substituted”. However, it is not clear what is encompassed by “having 2 to 15 carbon atoms that may be substituted… a sulfur atom or a nitrogen atom that may be substituted” because the claim fails to recite the type of substitution or with what the carbon atoms or the sulfur/nitrogen atoms get substituted. A person having ordinary skill in the art cannot recognize the metes and bounds of the claim.
Claim 5 recites the limitation "number of carbon atoms of L1" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is not clear what is meant by “L1” because “L1” is not recited in claims 1 or 5. A person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim.
Claim 29 recites “L2 represents an alkylene group or oxyalkylene group having 2 to 15 carbon atoms that may be substituted… and X represents a sulfur atom or a nitrogen atom that may be substituted”. ”. However, it is not clear what is encompassed by “having 2 to 15 carbon atoms that may be substituted… a sulfur atom or a nitrogen atom that may be substituted” because the claim fails to recite the type of substitution or with what the carbon atoms or the sulfur/nitrogen atoms get substituted. A person having ordinary skill in the art cannot recognize the metes and bounds of the claim.
Claim 29 recites the limitation "number of carbon atoms of L2" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is not clear what is meant by “L2” because “L2” is not recited in claims 1, 4 or 28-29. A person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim.
For these reasons, the claims are indefinite.
Response to Arguments
Applicant's arguments filed 2/10/2026 have been fully considered but they are not persuasive.
Regarding the 112b rejections,
Applicant argues that “the Examiner states the claims do not teach one of ordinary skill the scope of the claimed invention for the reasons noted. In response, the claims are above amended in order to address the Examiner's concerns. Accordingly, this rejection is overcome and withdrawal thereof is respectfully requested” (page 13 para. 2).
However, the amendments fail to address the indefiniteness of the claim stated in the Final Rejection (11/20/2025). In fact, the current amendments further contribute to the indefiniteness issue pointed out during the Final Rejection (11/20/2025), namely, that the claims as currently amended fail to clearly link the particle diameter to the carboxy group density incorporated into the swollen layer. Because of this, a person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim (see 112b rejection above for a complete analysis)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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